FDA allows marketing of first self-fitting hearing aid controlled by the user

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October 9, 2018

FDA allows marketing of first self-fitting hearing aid controlled by the user

FDA on October 5 authorized marketing of the first hearing aid that enables users to fit, program, and control the device on their own. The Bose Hearing Aid (Bose Corp.) is intended to amplify sounds for individuals aged 18 years or older with perceived mild to moderate hearing loss.

FDA on October 5 authorized marketing of the first hearing aid that enables users to fit, program, and control the device on their own. The Bose Hearing Aid (Bose Corp.) is intended to amplify sounds for individuals aged 18 years or older with perceived mild to moderate hearing loss. According to Malvina Eydelman, MD, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at FDA's Center for Devices and Radiological Health, "Today's marketing authorization provides certain patients with access to a new hearing aid that provides them with direct control over the fit and functionality of the device. The FDA is committed to ensuring that individuals with hearing loss have options for taking an active role in their health care." The Bose hearing aid must still comply with relevant federal and state laws regarding the sale of hearing aids, such as state laws that may require the devices to be purchased from or dispensed by a licensed hearing aid dispenser. FDA is now drafting proposed regulations for a category of OTC hearing aids as required by the FDA Reauthorization Act of 2017.